title: COMBIT: protocol of a randomised comparison trial of COMbined modified constraint induced movement therapy and bimanual intensive training with distributed model of standard upper limb rehabilitation in children with congenital hemiplegia.
abstract: BACKGROUND
  Children with congenital hemiplegia often present with limitations in using their impaired upper limb which impacts on independence in activities of daily living, societal participation and quality of life. Traditional therapy has adopted a bimanual training approach (BIM) and more recently, modified constraint induced movement therapy (mCIMT) has emerged as a promising unimanual approach. Evidence of enhanced neuroplasticity following mCIMT suggests that the sequential application of mCIMT followed by bimanual training may optimise outcomes (Hybrid CIMT). It remains unclear whether more intensely delivered group based interventions (hCIMT) are superior to distributed models of individualised therapy. This study aims to determine the optimal density of upper limb training for children with congenital hemiplegia.
  
  
  METHODS
  A total of 50 children (25 in each group) with congenital hemiplegia will be recruited to participate in this randomized comparison trial. Children will be matched in pairs at baseline and randomly allocated to receive an intensive block group hybrid model of combined mCIMT followed by intensive bimanual training delivered in a day camp model (COMBiT; total dose 45 hours direct, 10 hours of indirect therapy), or a distributed model of standard occupational therapy and physiotherapy care (SC) over 12 weeks (total 45 hours direct and indirect therapy). Outcomes will be assessed at 13 weeks after commencement, and retention of effects tested at 26 weeks. The primary outcomes will be bimanual coordination and unimanual upper-limb capacity. Secondary outcomes will be participation and quality of life. Advanced brain imaging will assess neurovascular changes in response to treatment. Analysis will follow standard principles for RCTs, using two-group comparisons on all participants on an intention-to-treat basis. Comparisons will be between treatment groups using generalized linear models.
  
  
  BACKGROUND
  ACTRN12613000181707.
authors.affiliation: Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, Faculty of Health Sciences, The University of Queensland, Brisbane, Australia. r.boyd@uq.edu.au
authors.forename: Roslyn N
authors.initials: RN
authors.lastname: Boyd
authors.forename: Jenny
authors.initials: J
authors.lastname: Ziviani
authors.forename: Leanne
authors.initials: L
authors.lastname: Sakzewski
authors.forename: Laura
authors.initials: L
authors.lastname: Miller
authors.forename: Joanne
authors.initials: J
authors.lastname: Bowden
authors.forename: Ross
authors.initials: R
authors.lastname: Cunnington
authors.forename: Robert
authors.initials: R
authors.lastname: Ware
authors.forename: Andrea
authors.initials: A
authors.lastname: Guzzetta
authors.forename: Richard
authors.initials: R
authors.lastname: Al Macdonell
authors.forename: Graeme D
authors.initials: GD
authors.lastname: Jackson
authors.forename: David F
authors.initials: DF
authors.lastname: Abbott
authors.forename: Stephen
authors.initials: S
authors.lastname: Rose
mesh_terms: D000293:Adolescent; D001921:Brain / Q000098:blood supply / Q000473:pathology; D002648:Child; D002675:Child, Preschool; D038524:Diffusion Magnetic Resonance Imaging; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D007839:Functional Laterality; D006429:Hemiplegia / Q000151:congenital* / Q000523:psychology / Q000534:rehabilitation*; D006801:Humans; D007091:Image Processing, Computer-Assisted; D008279:Magnetic Resonance Imaging; D008297:Male; D009042:Motivation; D009048:Motor Skills; D009413:Nerve Fibers, Myelinated / Q000473:pathology; D009460:Neurologic Examination; D010100:Oxygen / Q000097:blood; D026741:Physical Therapy Modalities; D055070:Resistance Training / Q000379:methods*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D034941:Upper Extremity / Q000502:physiology*
chemical_list: D010100:Oxygen